Ambu A/S - FDA 510(k) Cleared Devices
37
Total
37
Cleared
0
Denied
Ambu A/S has 37 FDA 510(k) cleared medical devices. Based in Glen Burnie, US.
Latest FDA clearance: Jun 2025. Active since 2005.
Browse the FDA 510(k) cleared devices submitted by Ambu A/S Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Ambu A/S
37 devices
Cleared
Jun 11, 2025
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
Gastroenterology & Urology
132d
Cleared
Oct 16, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
Gastroenterology & Urology
203d
Cleared
Oct 10, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
Gastroenterology & Urology
197d
Cleared
Aug 16, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
Gastroenterology & Urology
29d
Cleared
Jun 24, 2024
Ambu® aScope™ 5 Uretero (Standard Deflection)
Gastroenterology & Urology
224d
Cleared
Apr 16, 2024
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
Gastroenterology & Urology
130d
Cleared
Apr 05, 2024
Ambu® aScope™ Gastro Large
Gastroenterology & Urology
199d
Cleared
Jan 04, 2024
Ambu® aScope™ 5 Broncho 4.2/2.2
Ear, Nose, Throat
50d
Cleared
Sep 20, 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Ear, Nose, Throat
26d
Cleared
Sep 15, 2023
Ambu® aScope™ Colon
Gastroenterology & Urology
220d
Cleared
Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
Ear, Nose, Throat
174d
Cleared
Jun 01, 2023
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu®...
Ear, Nose, Throat
217d
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